{
"NDC": [
{
"NDCCode": "70692-843-40",
"PackageDescription": "400 CAPSULE, LIQUID FILLED in 1 BOTTLE (70692-843-40) ",
"NDC11Code": "70692-0843-40",
"ProductNDC": "70692-843",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Right Remedies Stool Softener Clear - Docusate Sodium 50mg Softgel",
"NonProprietaryName": "Right Remedies Stool Softener Clear Softgel",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20260904",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Strive Pharmaceuticals Inc.",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260904",
"SamplePackage": "N"
},
{
"NDCCode": "70692-843-81",
"PackageDescription": "180 CAPSULE, LIQUID FILLED in 1 BOTTLE (70692-843-81) ",
"NDC11Code": "70692-0843-81",
"ProductNDC": "70692-843",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Right Remedies Stool Softener Clear - Docusate Sodium 50mg Softgel",
"NonProprietaryName": "Right Remedies Stool Softener Clear Softgel",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20260904",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Strive Pharmaceuticals Inc.",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260904",
"SamplePackage": "N"
},
{
"NDCCode": "70692-148-40",
"PackageDescription": "400 TABLET in 1 BOTTLE (70692-148-40) ",
"NDC11Code": "70692-0148-40",
"ProductNDC": "70692-148",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diphenhydramine Hydrochloride 25mg",
"NonProprietaryName": "Diphenhydramine Hydrochloride 25mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181220",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Strive Pharmaceuticals Inc",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throattemporarily relieves these symptoms due to the common cold: runny nose sneezing."
},
{
"NDCCode": "70692-150-44",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (70692-150-44) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "70692-0150-44",
"ProductNDC": "70692-150",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Right Remedies Pain Relief Extra Strength Caplet",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220720",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Strive Pharmaceuticals Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231121",
"SamplePackage": "N",
"IndicationAndUsage": " temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever."
},
{
"NDCCode": "43063-843-40",
"PackageDescription": "40 TABLET in 1 BOTTLE, PLASTIC (43063-843-40) ",
"NDC11Code": "43063-0843-40",
"ProductNDC": "43063-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180405",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets are indicated for relief of mild to moderate pain. Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets in children have not been conducted.",
"Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen, USP is a white powder with a melting point of 74° to 77°C and is very slightly soluble in water (< 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide."
},
{
"NDCCode": "51523-843-27",
"PackageDescription": "1 TUBE in 1 CARTON (51523-843-27) > 40 g in 1 TUBE",
"NDC11Code": "51523-0843-27",
"ProductNDC": "51523-843",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Face It Power Perfection",
"ProprietaryNameSuffix": "32800843",
"NonProprietaryName": "Octinoxate, Titanium Dioxide And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141120",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "THEFACESHOP CO., LTD.",
"SubstanceName": "ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "1.2; 2; 3.9",
"StrengthUnit": "g/40g; g/40g; g/40g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "58602-843-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (58602-843-12) > 40 CAPSULE in 1 BOTTLE",
"NDC11Code": "58602-0843-12",
"ProductNDC": "58602-843",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207753",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200715",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachetoothache backachemenstrual crampsmuscular achesthe common cold minor pain of arthritis . temporarily reduces fever."
},
{
"NDCCode": "58602-843-70",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (58602-843-70) > 40 CAPSULE in 1 BOTTLE, PLASTIC",
"NDC11Code": "58602-0843-70",
"ProductNDC": "58602-843",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207753",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200827",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachetoothache backachemenstrual crampsmuscular achesthe common cold minor pain of arthritis . temporarily reduces fever."
},
{
"NDCCode": "72476-843-40",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (72476-843-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "72476-0843-40",
"ProductNDC": "72476-843",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen Minis",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20200630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206568",
"LabelerName": "Care One (Retail Business Services, LLC.)",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200630",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps . temporarily reduces fever."
},
{
"NDCCode": "16590-843-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (16590-843-90)",
"NDC11Code": "16590-0843-90",
"ProductNDC": "16590-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prozac",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19871229",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018936",
"LabelerName": "Stat Rx USA",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Prozac is indicated for the treatment of major depressive disorder. Adult — The efficacy of Prozac was established in 5– and 6–week trials with depressed adult and geriatric outpatients (≥18 years of age) whose diagnoses corresponded most closely to the DSM–III (currently DSM–IV) category of major depressive disorder (see CLINICAL TRIALS). A major depressive episode (DSM–IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effects of Prozac in hospitalized depressed patients have not been adequately studied. The efficacy of Prozac 20 mg once daily in maintaining a response in major depressive disorder for up to 38 weeks following 12 weeks of open–label acute treatment (50 weeks total) was demonstrated in a placebo–controlled trial. The efficacy of Prozac Weekly once weekly in maintaining a response in major depressive disorder has been demonstrated in a placebo–controlled trial for up to 25 weeks following open–label acute treatment of 13 weeks with Prozac 20 mg daily for a total treatment of 38 weeks. However, it is unknown whether or not Prozac Weekly given on a once–weekly basis provides the same level of protection from relapse as that provided by Prozac 20 mg daily (see CLINICAL TRIALS). Pediatric (children and adolescents) — The efficacy of Prozac in children and adolescents was established in two 8– to 9–week placebo–controlled clinical trials in depressed outpatients whose diagnoses corresponded most closely to the DSM–III–R or DSM–IV category of major depressive disorder (see CLINICAL TRIALS). The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should be reevaluated periodically. Adult — Prozac is indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in the DSM–III–R; i.e., the obsessions or compulsions cause marked distress, are time–consuming, or significantly interfere with social or occupational functioning. The efficacy of Prozac was established in 13–week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the DSM–III–R category of OCD (see CLINICAL TRIALS). OCD is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego–dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The effectiveness of Prozac in long–term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo–controlled trials. Therefore, the physician who elects to use Prozac for extended periods should periodically reevaluate the long–term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Pediatric (children and adolescents) — The efficacy of Prozac in children and adolescents was established in a 13–week, dose titration, clinical trial in patients with OCD, as defined in DSM–IV (see CLINICAL TRIALS). Prozac is indicated for the treatment of binge–eating and vomiting behaviors in patients with moderate to severe bulimia nervosa. The efficacy of Prozac was established in 8– to 16–week trials for adult outpatients with moderate to severe bulimia nervosa, i.e., at least 3 bulimic episodes per week for 6 months (see CLINICAL TRIALS). The efficacy of Prozac 60 mg/day in maintaining a response, in patients with bulimia who responded during an 8–week acute treatment phase while taking Prozac 60 mg/day and were then observed for relapse during a period of up to 52 weeks, was demonstrated in a placebo–controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use Prozac for extended periods should periodically reevaluate the long–term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Prozac is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM–IV. Panic disorder is characterized by the occurrence of unexpected panic attacks, and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Prozac was established in two 12–week clinical trials in patients whose diagnoses corresponded to the DSM–IV category of panic disorder (see CLINICAL TRIALS). Panic disorder (DSM–IV) is characterized by recurrent, unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which 4 or more of the following symptoms develop abruptly and reach a peak within 10 minutes: 1) palpitations, pounding heart, or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5) feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded, or faint; 9) fear of losing control; 10) fear of dying; 11) paresthesias (numbness or tingling sensations); 12) chills or hot flashes. The effectiveness of Prozac in long–term use, i.e., for more than 12 weeks, has not been established in placebo–controlled trials. Therefore, the physician who elects to use Prozac for extended periods should periodically reevaluate the long–term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Prozac® (fluoxetine capsules, USP and fluoxetine oral solution, USP) is a psychotropic drug for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off–white crystalline solid with a solubility of 14 mg/mL in water. Each Pulvule® contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The Pulvules also contain starch, gelatin, silicone, titanium dioxide, iron oxide, and other inactive ingredients. The 10– and 20–mg Pulvules also contain FDandC Blue No. 1, and the 40–mg Pulvule also contains FDnadC Blue No. 1 and FDandC Yellow No. 6. The oral solution contains fluoxetine hydrochloride equivalent to 20 mg/5 mL (64.7 μmol) of fluoxetine. It also contains alcohol 0.23%, benzoic acid, flavoring agent, glycerin, purified water, and sucrose. Prozac Weekly capsules, a delayed–release formulation, contain enteric–coated pellets of fluoxetine hydrochloride equivalent to 90 mg (291 μmol) of fluoxetine. The capsules also contain DandC Yellow No. 10, FDandC Blue No. 2, gelatin, hypromellose, hypromellose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, and other inactive ingredients."
},
{
"NDCCode": "21695-843-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (21695-843-60)",
"NDC11Code": "21695-0843-60",
"ProductNDC": "21695-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20031223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040496",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 750; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Dolgic Plus is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Dolgic Plus (Butalbital, Acetaminophen, and Caffeine USP) is supplied in tablet form for oral administration. Butalbital (5-allyl-5-isobutyl-barbituric acid), a white, odorless crystalline powder having a slightly bitter taste, is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine),a bitter, white crystalline powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula. Each Dolgic Plus tablet contains. Butalbital, USP 50 mg. Acetaminophen, USP 500 mg. Caffeine, USP 40 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, povidone, microcrystalline cellulose, pregelatinized corn starch and stearic acid. Film coating composed of: carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, D&C Red No. 30 aluminum lake."
},
{
"NDCCode": "33261-843-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (33261-843-60)",
"NDC11Code": "33261-0843-60",
"ProductNDC": "33261-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077636",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
"Description": "Zonisamide capsule is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The empirical formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is. Zonisamide capsules are supplied for oral administration as capsules containing 25 mg, 50 mg and 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, sodium lauryl sulfate, hydrogenated vegetable oil, colloidal silicon dioxide, sodium starch glycolate, talc, gelatin, titanium dioxide. For 100 mg D&C red # 28, D&C yellow # 10, and FD&C # yellow 6 and for 50 mg contains FD&C red # 40, FD&C yellow # 5, and FD&C Blue # 1."
},
{
"NDCCode": "43353-843-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (43353-843-60) ",
"NDC11Code": "43353-0843-60",
"ProductNDC": "43353-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076477",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180628",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*,R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium, USP is a white to off-white crystalline powder. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble to insoluble in water and pH 7.4 phosphate buffer; insoluble in acetonitrile; slightly soluble to very slightly soluble in ethanol; and freely soluble to slightly soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate; candelilla wax, FCC; croscarmellose sodium; hydroxypropyl cellulose; hypromellose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polysorbate 80; simethicone emulsion; talc, and titanium dioxide."
},
{
"NDCCode": "49035-843-37",
"PackageDescription": "156 g in 1 CAN (49035-843-37) ",
"NDC11Code": "49035-0843-37",
"ProductNDC": "49035-843",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Sunscreen Spf 50 Sport",
"ProprietaryNameSuffix": "Broadspectrum",
"NonProprietaryName": "Avobenzone,homosalate,octisalate,octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190129",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Walmart",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 50; 40",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190129",
"SamplePackage": "N"
},
{
"NDCCode": "49035-843-39",
"PackageDescription": "312 g in 1 CAN (49035-843-39) ",
"NDC11Code": "49035-0843-39",
"ProductNDC": "49035-843",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Sunscreen Spf 50 Sport",
"ProprietaryNameSuffix": "Broadspectrum",
"NonProprietaryName": "Avobenzone,homosalate,octisalate,octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190129",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Walmart",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 50; 40",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190129",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "49035-843-48",
"PackageDescription": "258 g in 1 CAN (49035-843-48) ",
"NDC11Code": "49035-0843-48",
"ProductNDC": "49035-843",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Sunscreen Spf 50 Sport",
"ProprietaryNameSuffix": "Broadspectrum",
"NonProprietaryName": "Avobenzone,homosalate,octisalate,octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190129",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Walmart",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 50; 40",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190129",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "49035-843-63",
"PackageDescription": "2 CAN in 1 PACKAGE (49035-843-63) / 156 g in 1 CAN (49035-843-37) ",
"NDC11Code": "49035-0843-63",
"ProductNDC": "49035-843",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Sunscreen Spf 50 Sport",
"ProprietaryNameSuffix": "Broadspectrum",
"NonProprietaryName": "Avobenzone,homosalate,octisalate,octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190129",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Walmart",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 50; 40",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190129",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "49035-843-78",
"PackageDescription": "516 g in 1 CAN (49035-843-78) ",
"NDC11Code": "49035-0843-78",
"ProductNDC": "49035-843",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Sunscreen Spf 50 Sport",
"ProprietaryNameSuffix": "Broadspectrum",
"NonProprietaryName": "Avobenzone,homosalate,octisalate,octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190129",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Walmart",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 50; 40",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190129",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "57297-843-13",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (57297-843-13) > 1 KIT in 1 BLISTER PACK (57297-843-11)",
"NDC11Code": "57297-0843-13",
"ProductNDC": "57297-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20121024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091440",
"LabelerName": "LUPIN LIMITED",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Levonorgestrel and Ethinyl Estradiol Tablets USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. In a 1-year controlled clinical trial, 4 pregnancies occurred in women 18 to 35 years of age during 809 completed 91-day cycles of levonorgestrel and ethinyl estradiol tablets during which no backup contraception was utilized. This represents an overall use-efficacy (typical user efficacy) Pregnancy rate of 1.98 per 100 women-years of use. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® Implant System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Levonorgestrel and ethinyl estradiol tablets USP are an extended-cycle oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 white inert tablets (without hormones). The chemical formula of levonorgestrel USP is 18, 19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-, and the chemical formula of ethinyl estradiol USP is 19-Norpregna-1, 3, 5(10)-trien-20-yne-3, 17-diol, (17α)-. The structural formulas are as follows. Each pink active tablet contains the following inactive ingredients: croscarmellose sodium, FD & C Blue # 1, FD & C Red # 40, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide. Each white inert tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "59651-843-01",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-01) ",
"NDC11Code": "59651-0843-01",
"ProductNDC": "59651-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075281",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250417",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.",
"Description": "Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "59651-843-05",
"PackageDescription": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-05) ",
"NDC11Code": "59651-0843-05",
"ProductNDC": "59651-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075281",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250417",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.",
"Description": "Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "59651-843-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-60) ",
"NDC11Code": "59651-0843-60",
"ProductNDC": "59651-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075281",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250417",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.",
"Description": "Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "59651-843-99",
"PackageDescription": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-99) ",
"NDC11Code": "59651-0843-99",
"ProductNDC": "59651-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075281",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250417",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.",
"Description": "Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "60760-843-07",
"PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-843-07) ",
"NDC11Code": "60760-0843-07",
"ProductNDC": "60760-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215630",
"LabelerName": "ST. MARY'S MEDICAL PARK PHARMACY",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230620",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.",
"Description": "The active ingredient in famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is. N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3and its molecular weight is 337.43. Its structural formula is:. Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate (type-A), hypromellose, titanium dioxide, triacetin, talc and macrogol. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
},
{
"NDCCode": "60760-843-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-843-60) ",
"NDC11Code": "60760-0843-60",
"ProductNDC": "60760-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215630",
"LabelerName": "ST. MARY'S MEDICAL PARK PHARMACY",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230701",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.",
"Description": "The active ingredient in famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is. N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3and its molecular weight is 337.43. Its structural formula is:. Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate (type-A), hypromellose, titanium dioxide, triacetin, talc and macrogol. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
},
{
"NDCCode": "67877-843-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (67877-843-01) ",
"NDC11Code": "67877-0843-01",
"ProductNDC": "67877-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215630",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220708",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.",
"Description": "The active ingredient in famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is. N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate (type-A), hypromellose, titanium dioxide, triacetin, talc and macrogol. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
},
{
"NDCCode": "67877-843-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (67877-843-05) ",
"NDC11Code": "67877-0843-05",
"ProductNDC": "67877-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215630",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220708",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.",
"Description": "The active ingredient in famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is. N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate (type-A), hypromellose, titanium dioxide, triacetin, talc and macrogol. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
},
{
"NDCCode": "68180-843-13",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68180-843-13) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "68180-0843-13",
"ProductNDC": "68180-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20121024",
"EndMarketingDate": "20281031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091440",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121024",
"EndMarketingDatePackage": "20281031",
"SamplePackage": "N",
"IndicationAndUsage": "Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Levonorgestrel and ethinyl estradiol tablets USP are an extended-cycle combination oral contraceptive consisting of 84 pink, round, biconvex, film-coated, active tablets, each containing 0.15 mg of levonorgestrel USP, a synthetic progestin and 0.03 mg of ethinyl estradiol USP, an estrogen, and 7 white to off white, round, biconvex, inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each pink active tablet contains the following inactive ingredients: croscarmellose sodium, FD & C Blue # 1, FD & C Red # 40, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide., 2 Each white to off white inert tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "69097-843-05",
"PackageDescription": "90 TABLET in 1 BOTTLE (69097-843-05) ",
"NDC11Code": "69097-0843-05",
"ProductNDC": "69097-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinapril",
"NonProprietaryName": "Quinapril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078457",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160722",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Quinapril is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Quinapril may be used alone or in combination with thiazide diuretics. Heart Failure. Quinapril is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril does not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.",
"Description": "Quinapril hydrochloride, USP is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride, USP is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 HCl and its structural formula is. Quinapril hydrochloride, USP is a white to off-white amorphous powder that is freely soluble in aqueous solvents. Quinapril tablets, USP contain quinapril hydrochloride equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of quinapril for oral administration. Each tablet also contains lactose monohydrate, magnesium carbonate, magnesium stearate, crospovidone, povidone and opadry brown (hypromellose, titanium dioxide, iron oxide and macrogol)."
},
{
"NDCCode": "69097-843-15",
"PackageDescription": "1000 TABLET in 1 BOTTLE (69097-843-15) ",
"NDC11Code": "69097-0843-15",
"ProductNDC": "69097-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinapril",
"NonProprietaryName": "Quinapril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078457",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160722",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Quinapril is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Quinapril may be used alone or in combination with thiazide diuretics. Heart Failure. Quinapril is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril does not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.",
"Description": "Quinapril hydrochloride, USP is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride, USP is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 HCl and its structural formula is. Quinapril hydrochloride, USP is a white to off-white amorphous powder that is freely soluble in aqueous solvents. Quinapril tablets, USP contain quinapril hydrochloride equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of quinapril for oral administration. Each tablet also contains lactose monohydrate, magnesium carbonate, magnesium stearate, crospovidone, povidone and opadry brown (hypromellose, titanium dioxide, iron oxide and macrogol)."
}
]
}
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<PackageDescription>400 CAPSULE, LIQUID FILLED in 1 BOTTLE (70692-843-40) </PackageDescription>
<NDC11Code>70692-0843-40</NDC11Code>
<ProductNDC>70692-843</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Right Remedies Stool Softener Clear - Docusate Sodium 50mg Softgel</ProprietaryName>
<NonProprietaryName>Right Remedies Stool Softener Clear Softgel</NonProprietaryName>
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<SubstanceName>DOCUSATE SODIUM</SubstanceName>
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<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70692-843-81</NDCCode>
<PackageDescription>180 CAPSULE, LIQUID FILLED in 1 BOTTLE (70692-843-81) </PackageDescription>
<NDC11Code>70692-0843-81</NDC11Code>
<ProductNDC>70692-843</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Right Remedies Stool Softener Clear - Docusate Sodium 50mg Softgel</ProprietaryName>
<NonProprietaryName>Right Remedies Stool Softener Clear Softgel</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<LabelerName>Strive Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>70692-148-40</NDCCode>
<PackageDescription>400 TABLET in 1 BOTTLE (70692-148-40) </PackageDescription>
<NDC11Code>70692-0148-40</NDC11Code>
<ProductNDC>70692-148</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diphenhydramine Hydrochloride 25mg</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride 25mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Strive Pharmaceuticals Inc</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
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<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throattemporarily relieves these symptoms due to the common cold: runny nose sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70692-150-44</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (70692-150-44) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>70692-0150-44</NDC11Code>
<ProductNDC>70692-150</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Right Remedies Pain Relief Extra Strength Caplet</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220720</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Strive Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever.</IndicationAndUsage>
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<NDC>
<NDCCode>43063-843-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE, PLASTIC (43063-843-40) </PackageDescription>
<NDC11Code>43063-0843-40</NDC11Code>
<ProductNDC>43063-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets are indicated for relief of mild to moderate pain. Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen, USP is a white powder with a melting point of 74° to 77°C and is very slightly soluble in water (< 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51523-843-27</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51523-843-27) > 40 g in 1 TUBE</PackageDescription>
<NDC11Code>51523-0843-27</NDC11Code>
<ProductNDC>51523-843</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Face It Power Perfection</ProprietaryName>
<ProprietaryNameSuffix>32800843</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>THEFACESHOP CO., LTD.</LabelerName>
<SubstanceName>ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.2; 2; 3.9</StrengthNumber>
<StrengthUnit>g/40g; g/40g; g/40g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58602-843-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58602-843-12) > 40 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>58602-0843-12</NDC11Code>
<ProductNDC>58602-843</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207753</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachetoothache backachemenstrual crampsmuscular achesthe common cold minor pain of arthritis . temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-843-70</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (58602-843-70) > 40 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>58602-0843-70</NDC11Code>
<ProductNDC>58602-843</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207753</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachetoothache backachemenstrual crampsmuscular achesthe common cold minor pain of arthritis . temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72476-843-40</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (72476-843-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>72476-0843-40</NDC11Code>
<ProductNDC>72476-843</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen Minis</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206568</ApplicationNumber>
<LabelerName>Care One (Retail Business Services, LLC.)</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps . temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16590-843-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (16590-843-90)</PackageDescription>
<NDC11Code>16590-0843-90</NDC11Code>
<ProductNDC>16590-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prozac</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19871229</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018936</ApplicationNumber>
<LabelerName>Stat Rx USA</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prozac is indicated for the treatment of major depressive disorder. Adult — The efficacy of Prozac was established in 5– and 6–week trials with depressed adult and geriatric outpatients (≥18 years of age) whose diagnoses corresponded most closely to the DSM–III (currently DSM–IV) category of major depressive disorder (see CLINICAL TRIALS). A major depressive episode (DSM–IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effects of Prozac in hospitalized depressed patients have not been adequately studied. The efficacy of Prozac 20 mg once daily in maintaining a response in major depressive disorder for up to 38 weeks following 12 weeks of open–label acute treatment (50 weeks total) was demonstrated in a placebo–controlled trial. The efficacy of Prozac Weekly once weekly in maintaining a response in major depressive disorder has been demonstrated in a placebo–controlled trial for up to 25 weeks following open–label acute treatment of 13 weeks with Prozac 20 mg daily for a total treatment of 38 weeks. However, it is unknown whether or not Prozac Weekly given on a once–weekly basis provides the same level of protection from relapse as that provided by Prozac 20 mg daily (see CLINICAL TRIALS). Pediatric (children and adolescents) — The efficacy of Prozac in children and adolescents was established in two 8– to 9–week placebo–controlled clinical trials in depressed outpatients whose diagnoses corresponded most closely to the DSM–III–R or DSM–IV category of major depressive disorder (see CLINICAL TRIALS). The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should be reevaluated periodically. Adult — Prozac is indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in the DSM–III–R; i.e., the obsessions or compulsions cause marked distress, are time–consuming, or significantly interfere with social or occupational functioning. The efficacy of Prozac was established in 13–week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the DSM–III–R category of OCD (see CLINICAL TRIALS). OCD is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego–dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The effectiveness of Prozac in long–term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo–controlled trials. Therefore, the physician who elects to use Prozac for extended periods should periodically reevaluate the long–term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Pediatric (children and adolescents) — The efficacy of Prozac in children and adolescents was established in a 13–week, dose titration, clinical trial in patients with OCD, as defined in DSM–IV (see CLINICAL TRIALS). Prozac is indicated for the treatment of binge–eating and vomiting behaviors in patients with moderate to severe bulimia nervosa. The efficacy of Prozac was established in 8– to 16–week trials for adult outpatients with moderate to severe bulimia nervosa, i.e., at least 3 bulimic episodes per week for 6 months (see CLINICAL TRIALS). The efficacy of Prozac 60 mg/day in maintaining a response, in patients with bulimia who responded during an 8–week acute treatment phase while taking Prozac 60 mg/day and were then observed for relapse during a period of up to 52 weeks, was demonstrated in a placebo–controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use Prozac for extended periods should periodically reevaluate the long–term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Prozac is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM–IV. Panic disorder is characterized by the occurrence of unexpected panic attacks, and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Prozac was established in two 12–week clinical trials in patients whose diagnoses corresponded to the DSM–IV category of panic disorder (see CLINICAL TRIALS). Panic disorder (DSM–IV) is characterized by recurrent, unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which 4 or more of the following symptoms develop abruptly and reach a peak within 10 minutes: 1) palpitations, pounding heart, or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5) feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded, or faint; 9) fear of losing control; 10) fear of dying; 11) paresthesias (numbness or tingling sensations); 12) chills or hot flashes. The effectiveness of Prozac in long–term use, i.e., for more than 12 weeks, has not been established in placebo–controlled trials. Therefore, the physician who elects to use Prozac for extended periods should periodically reevaluate the long–term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Prozac® (fluoxetine capsules, USP and fluoxetine oral solution, USP) is a psychotropic drug for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off–white crystalline solid with a solubility of 14 mg/mL in water. Each Pulvule® contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The Pulvules also contain starch, gelatin, silicone, titanium dioxide, iron oxide, and other inactive ingredients. The 10– and 20–mg Pulvules also contain FDandC Blue No. 1, and the 40–mg Pulvule also contains FDnadC Blue No. 1 and FDandC Yellow No. 6. The oral solution contains fluoxetine hydrochloride equivalent to 20 mg/5 mL (64.7 μmol) of fluoxetine. It also contains alcohol 0.23%, benzoic acid, flavoring agent, glycerin, purified water, and sucrose. Prozac Weekly capsules, a delayed–release formulation, contain enteric–coated pellets of fluoxetine hydrochloride equivalent to 90 mg (291 μmol) of fluoxetine. The capsules also contain DandC Yellow No. 10, FDandC Blue No. 2, gelatin, hypromellose, hypromellose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, and other inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>21695-843-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (21695-843-60)</PackageDescription>
<NDC11Code>21695-0843-60</NDC11Code>
<ProductNDC>21695-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040496</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 750; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Dolgic Plus is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Dolgic Plus (Butalbital, Acetaminophen, and Caffeine USP) is supplied in tablet form for oral administration. Butalbital (5-allyl-5-isobutyl-barbituric acid), a white, odorless crystalline powder having a slightly bitter taste, is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine),a bitter, white crystalline powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula. Each Dolgic Plus tablet contains. Butalbital, USP 50 mg. Acetaminophen, USP 500 mg. Caffeine, USP 40 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, povidone, microcrystalline cellulose, pregelatinized corn starch and stearic acid. Film coating composed of: carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, D&C Red No. 30 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>33261-843-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (33261-843-60)</PackageDescription>
<NDC11Code>33261-0843-60</NDC11Code>
<ProductNDC>33261-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077636</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
<Description>Zonisamide capsule is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The empirical formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is. Zonisamide capsules are supplied for oral administration as capsules containing 25 mg, 50 mg and 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, sodium lauryl sulfate, hydrogenated vegetable oil, colloidal silicon dioxide, sodium starch glycolate, talc, gelatin, titanium dioxide. For 100 mg D&C red # 28, D&C yellow # 10, and FD&C # yellow 6 and for 50 mg contains FD&C red # 40, FD&C yellow # 5, and FD&C Blue # 1.</Description>
</NDC>
<NDC>
<NDCCode>43353-843-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (43353-843-60) </PackageDescription>
<NDC11Code>43353-0843-60</NDC11Code>
<ProductNDC>43353-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076477</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*,R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium, USP is a white to off-white crystalline powder. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble to insoluble in water and pH 7.4 phosphate buffer; insoluble in acetonitrile; slightly soluble to very slightly soluble in ethanol; and freely soluble to slightly soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate; candelilla wax, FCC; croscarmellose sodium; hydroxypropyl cellulose; hypromellose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polysorbate 80; simethicone emulsion; talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49035-843-37</NDCCode>
<PackageDescription>156 g in 1 CAN (49035-843-37) </PackageDescription>
<NDC11Code>49035-0843-37</NDC11Code>
<ProductNDC>49035-843</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Sunscreen Spf 50 Sport</ProprietaryName>
<ProprietaryNameSuffix>Broadspectrum</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone,homosalate,octisalate,octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Walmart</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 50; 40</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49035-843-39</NDCCode>
<PackageDescription>312 g in 1 CAN (49035-843-39) </PackageDescription>
<NDC11Code>49035-0843-39</NDC11Code>
<ProductNDC>49035-843</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Sunscreen Spf 50 Sport</ProprietaryName>
<ProprietaryNameSuffix>Broadspectrum</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone,homosalate,octisalate,octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Walmart</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 50; 40</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49035-843-48</NDCCode>
<PackageDescription>258 g in 1 CAN (49035-843-48) </PackageDescription>
<NDC11Code>49035-0843-48</NDC11Code>
<ProductNDC>49035-843</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Sunscreen Spf 50 Sport</ProprietaryName>
<ProprietaryNameSuffix>Broadspectrum</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone,homosalate,octisalate,octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Walmart</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 50; 40</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49035-843-63</NDCCode>
<PackageDescription>2 CAN in 1 PACKAGE (49035-843-63) / 156 g in 1 CAN (49035-843-37) </PackageDescription>
<NDC11Code>49035-0843-63</NDC11Code>
<ProductNDC>49035-843</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Sunscreen Spf 50 Sport</ProprietaryName>
<ProprietaryNameSuffix>Broadspectrum</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone,homosalate,octisalate,octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Walmart</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 50; 40</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49035-843-78</NDCCode>
<PackageDescription>516 g in 1 CAN (49035-843-78) </PackageDescription>
<NDC11Code>49035-0843-78</NDC11Code>
<ProductNDC>49035-843</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Sunscreen Spf 50 Sport</ProprietaryName>
<ProprietaryNameSuffix>Broadspectrum</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone,homosalate,octisalate,octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Walmart</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 50; 40</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57297-843-13</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (57297-843-13) > 1 KIT in 1 BLISTER PACK (57297-843-11)</PackageDescription>
<NDC11Code>57297-0843-13</NDC11Code>
<ProductNDC>57297-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonorgestrel And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20121024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091440</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Levonorgestrel and Ethinyl Estradiol Tablets USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. In a 1-year controlled clinical trial, 4 pregnancies occurred in women 18 to 35 years of age during 809 completed 91-day cycles of levonorgestrel and ethinyl estradiol tablets during which no backup contraception was utilized. This represents an overall use-efficacy (typical user efficacy) Pregnancy rate of 1.98 per 100 women-years of use. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® Implant System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Levonorgestrel and ethinyl estradiol tablets USP are an extended-cycle oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 white inert tablets (without hormones). The chemical formula of levonorgestrel USP is 18, 19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-, and the chemical formula of ethinyl estradiol USP is 19-Norpregna-1, 3, 5(10)-trien-20-yne-3, 17-diol, (17α)-. The structural formulas are as follows. Each pink active tablet contains the following inactive ingredients: croscarmellose sodium, FD & C Blue # 1, FD & C Red # 40, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide. Each white inert tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>59651-843-01</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-01) </PackageDescription>
<NDC11Code>59651-0843-01</NDC11Code>
<ProductNDC>59651-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075281</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.</IndicationAndUsage>
<Description>Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>59651-843-05</NDCCode>
<PackageDescription>500 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-05) </PackageDescription>
<NDC11Code>59651-0843-05</NDC11Code>
<ProductNDC>59651-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075281</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.</IndicationAndUsage>
<Description>Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>59651-843-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-60) </PackageDescription>
<NDC11Code>59651-0843-60</NDC11Code>
<ProductNDC>59651-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075281</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.</IndicationAndUsage>
<Description>Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>59651-843-99</NDCCode>
<PackageDescription>1000 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-99) </PackageDescription>
<NDC11Code>59651-0843-99</NDC11Code>
<ProductNDC>59651-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075281</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.</IndicationAndUsage>
<Description>Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>60760-843-07</NDCCode>
<PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-843-07) </PackageDescription>
<NDC11Code>60760-0843-07</NDC11Code>
<ProductNDC>60760-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215630</ApplicationNumber>
<LabelerName>ST. MARY'S MEDICAL PARK PHARMACY</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is. N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3and its molecular weight is 337.43. Its structural formula is:. Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate (type-A), hypromellose, titanium dioxide, triacetin, talc and macrogol. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>60760-843-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-843-60) </PackageDescription>
<NDC11Code>60760-0843-60</NDC11Code>
<ProductNDC>60760-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215630</ApplicationNumber>
<LabelerName>ST. MARY'S MEDICAL PARK PHARMACY</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is. N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3and its molecular weight is 337.43. Its structural formula is:. Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate (type-A), hypromellose, titanium dioxide, triacetin, talc and macrogol. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>67877-843-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (67877-843-01) </PackageDescription>
<NDC11Code>67877-0843-01</NDC11Code>
<ProductNDC>67877-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215630</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is. N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate (type-A), hypromellose, titanium dioxide, triacetin, talc and macrogol. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>67877-843-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (67877-843-05) </PackageDescription>
<NDC11Code>67877-0843-05</NDC11Code>
<ProductNDC>67877-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215630</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is. N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate (type-A), hypromellose, titanium dioxide, triacetin, talc and macrogol. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>68180-843-13</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68180-843-13) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68180-0843-13</NDC11Code>
<ProductNDC>68180-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonorgestrel And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20121024</StartMarketingDate>
<EndMarketingDate>20281031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091440</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20121024</StartMarketingDatePackage>
<EndMarketingDatePackage>20281031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Levonorgestrel and ethinyl estradiol tablets USP are an extended-cycle combination oral contraceptive consisting of 84 pink, round, biconvex, film-coated, active tablets, each containing 0.15 mg of levonorgestrel USP, a synthetic progestin and 0.03 mg of ethinyl estradiol USP, an estrogen, and 7 white to off white, round, biconvex, inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each pink active tablet contains the following inactive ingredients: croscarmellose sodium, FD & C Blue # 1, FD & C Red # 40, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide., 2 Each white to off white inert tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>69097-843-05</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (69097-843-05) </PackageDescription>
<NDC11Code>69097-0843-05</NDC11Code>
<ProductNDC>69097-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quinapril</ProprietaryName>
<NonProprietaryName>Quinapril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078457</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>QUINAPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. Quinapril is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Quinapril may be used alone or in combination with thiazide diuretics. Heart Failure. Quinapril is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril does not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.</IndicationAndUsage>
<Description>Quinapril hydrochloride, USP is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride, USP is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 HCl and its structural formula is. Quinapril hydrochloride, USP is a white to off-white amorphous powder that is freely soluble in aqueous solvents. Quinapril tablets, USP contain quinapril hydrochloride equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of quinapril for oral administration. Each tablet also contains lactose monohydrate, magnesium carbonate, magnesium stearate, crospovidone, povidone and opadry brown (hypromellose, titanium dioxide, iron oxide and macrogol).</Description>
</NDC>
<NDC>
<NDCCode>69097-843-15</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (69097-843-15) </PackageDescription>
<NDC11Code>69097-0843-15</NDC11Code>
<ProductNDC>69097-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quinapril</ProprietaryName>
<NonProprietaryName>Quinapril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078457</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>QUINAPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. Quinapril is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Quinapril may be used alone or in combination with thiazide diuretics. Heart Failure. Quinapril is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril does not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.</IndicationAndUsage>
<Description>Quinapril hydrochloride, USP is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride, USP is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 HCl and its structural formula is. Quinapril hydrochloride, USP is a white to off-white amorphous powder that is freely soluble in aqueous solvents. Quinapril tablets, USP contain quinapril hydrochloride equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of quinapril for oral administration. Each tablet also contains lactose monohydrate, magnesium carbonate, magnesium stearate, crospovidone, povidone and opadry brown (hypromellose, titanium dioxide, iron oxide and macrogol).</Description>
</NDC>
</NDCList>